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A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

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Trial Profile

A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2026

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At a glance

  • Drugs Amivantamab (Primary) ; Fluorouracil (Primary) ; Folinic acid (Primary) ; Irinotecan (Primary) ; Levofolinic acid (Primary) ; Oxaliplatin (Primary) ; Cetuximab
  • Indications Adenocarcinoma; Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms OrigAMI-2
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 08 May 2026 Planned End Date changed from 30 Jan 2032 to 20 Jan 2032.
  • 19 Mar 2026 Planned End Date changed from 20 Jan 2032 to 30 Jan 2032.
  • 13 Feb 2026 Planned End Date changed from 15 Dec 2032 to 20 Jan 2032.

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